MEDINA - metabolický syndrom, diabetes mellitus a nefroprotektivita - Medina
- Conditions
- Metabolic syndrome (at least 2criteria) or diabetes mellistus type II. and primary hypertension
- Registration Number
- EUCTR2008-004668-38-CZ
- Lead Sponsor
- DSC Services, s.r.o.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Diabetes mellitus type II. and primary hypertension (systolic pressure > 130 mmHg or diastolic pressure > 85 mmHg )
Two criteria of metabolic syndrome
Age > 40
Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Myocardial infarction, stroke, PTCA, CABG in the last 3 months
Secondary hypertension
Clinically apparent heart failure
Diabetes mellitus type I.
Comorbidity with bad prognosis (death expectation > 30%)
Gravidity and fertile women without sufficient contraception
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective is to lower the absolute risk evaluated by SCORE as well as to increase the number of patients with SCORE level below 5%.;Secondary Objective: Percentage of patients with blood pressure < 140/90 mmHg.<br>Percentage of patients with cholesterol < 5,0 mmol/l.<br>Percentage of patients not complying with the criteria for metabolic syndrome.<br>Renal function evaluated as glomerular filtration and microalbuminuria.<br>Variation in glycated hemoglobin.<br>;Primary end point(s): SCORE
- Secondary Outcome Measures
Name Time Method